Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | GYNECARE INTERCEED™ Absorbable Adhesion Barrier |
Generic Name | Barrier, absorbable, adhesion |
Applicant | ETHICON, INC. 1000 Route 202 Raritan, NJ 08869 |
PMA Number | P880047 |
Supplement Number | S046 |
Date Received | 10/25/2021 |
Decision Date | 06/15/2022 |
Product Code |
MCN |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for updates to the device instructions for use and other product labeling related to MRI safety, Carcinogenic, Mutagenic, Toxic to Reproduction (CMR) and Endocrine Disruption (ED) safety, and administrative/clerical changes. |
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